Intro to APQP on Site PPAP Training

7/25/2019 Intro to APQP on Site PPAP Training

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2013 Eaton. All Rights Reserved.

Eaton PPAP - 101


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2 2013 Eaton. All Rights Reserved.

Introductions

Name

Organization

Current Role

Experience with PPAP

Experience or training with tools of PPAP:

MSA & Capability Studies


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Roles/ Responsibilities

Eaton Supp l ier Qual ity

Qualify suppliers

Determine PPAP requirements

Request PPAP(WISPER/QPulse) fromSupplier

Facilitate Design andSpecification Review(DSR/PFA)

Track/ review APQP activitiesfor accuracy and completion

Assist with suppliers activitiesas necessary

Review and approve PPAPsubmission

Monitor production, includingSC process capability

Suppl ier

Complete systems level correctiveactions as necessary per SupplierAssessment

Obtain and review complete designrecord, including all necessary

design drawings and specifications Review design for manufacturability

Participate in DSR and sign off

Develop and validate manufacturingprocess, including APQP activities

Submit PPAP to Eaton

Maintain Living documents withrespect to product/ process qualitycontrol


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Advanced Product Quality

Planning Cycle

Advanced Product Quality Planning

method to assure that a product satisfies

the customer (both internal and external).

The goal of APQP is to facilitate

communication with everyone and toassure that all required steps are

completed on time

What is APQP?

Each Advanced Product Quality Plan is unique and is a living document.

Particular emphasis must be placed on identifying high risk long lead

requirements or items which require focused upfront, effort.


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Expectations:

Supplier/external:

Understand Eaton APQP / Phase Review Discipline requirements.

Attend web overview training sessions.

Review AIAG manuals for APQP & PPAP and work accordingly.

www.aiag.org

Submit PPAPs on required product, parts, products or components.

Focus on up front quality planning.

Follow Supplier Excellence Manual Dictates

Provide PPAP submissions compliant with the Latest CPSD PPAP

Manual (Level 3 is default!)
http://www.aiag.org/http://www.aiag.org/


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4. Product and Process Validation

Measurement Systems

Evaluation

Significant Production Run

Preliminary Process Capability

Study

Production Part Approval

Production Validation Testing

Packaging Evaluation

Production Control Plan

Quality Planning Sign-Off -

formal

Management Support

INPUTS: OUTPUTS:

Validate manufacturing

process through

production trial run.

Validate that the controlplan and process flow

chart are effective and

that the product meets

customer expectation.

Packaging Standards

Product/Process Quality System

Review

Process Flow Chart

Floor Plan Layout

Characteristics Matrix

Process Failure Mode and

Effects Analysis (PFMEA)

Pre-Launch Control Plan

Process Instructions

Measurement Systems AnalysisPlan

Preliminary Process Capability

Study Plan

Packaging Specifications

Management Support


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Production Part ApprovalProcess (PPAP)

Eatons Cooper Power Systems Division

Launch

Approve Va

lidate

Design

Plan

Maintain high quality products while keeping projects on schedule

with transparent task management and collaboration tools.



What is the Purpose of PPAP?

When is PPAP Required?

What are the Elements of the submission?

How are the Levels of PPAP applied?

Details on successful PPAP submission to CPSD facilities

PPAP Training Objectives



What is PPAP?

Production Part Approval Process Standard used to formally reduce risks prior to product

or service release, in a team oriented manner using wellestablished tools and techniques

Initially developed by AIAG (Auto Industry Action Group)in 1993 with input from the Big 3 - Ford, Chrysler, andGM

AIAGs 4thedition effective June 1, 2006 is the mostrecent version

PPAP has now spread to many different industriesbeyond automotive

Outlines customer requirements that must be deliveredand approved prior to production of product



Purpose of PPAP

Provide evidence that all customer

engineering design record and specification

requirements are properly understood by the

organization

To demonstrate that the manufacturing

process has the potential to produce product

that consistently meets all requirements duringan actual production run at the quoted

production rate



Implementing PPAP with Value to the business

The Automotive Industry applied PPAP to all parts sourced from suppliers Eaton requires all purchased direct material components to have some

level of PPAP

CPSD will determine what level to apply to specific products based on

criteria

High Risk Part High Volume or Spend

New Technology

New Supplier

PPAP is applied to both:

New Products

Changes to existing products



Benefits of PPAP Submissions

Forces formal part conformance and approval

Ensures formal quality planning

Helps to maintain design integrity

Identifies issues early for resolution

Reduces warranty charges and prevents costs of poor quality

Assists with managing supplier changes

Prevents use of unapproved and nonconforming parts

Identifies suppliers that need more development

Improves the overall quality of the product & customer satisfaction



PPAP Requirements

What are the actual requirements?



The Basics of PPAP

Submission requirements are called

Elements

Which element is required is determined

by the submission

Level


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1. Part Submission Warrant2. Design Record

3. Engineering Change Documents, if any

4. Customer Engineering approval, if required

5. Design FMEA

6. Process Flow Diagrams

7. Process FMEA

8. Control Plan

9. Measurement System Analysis studies

10. Dimensional Results

11. Material, Performance Test Results

12. Initial Process Studies

13. Qualified Laboratory Documentation

14. Appearance Approval Report (AAR), if applicable

15. Sample Product

16. Master Sample17. Checking Aids

18. Records of Compliance With Customer Specific Requirements

19. Part Submission Warrant

20. Bulk Material Checklist

PPAP Elements (Requirements)


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Level 1 Production Warrant and Appearance ApprovalReport (if applicable) submitted to Eaton

Level 2Production Warrant, product samples, and

dimensional results submitted to Eaton

Level 3Production Warrant, product samples, and

complete supporting data submitted to Eaton

Level 4Production Warrant and other requirements

as defined by Eaton

Level 5

Production Warrant, product samples and

complete supporting data (a review will be

conducted at the supplier's manufacturing

location)

PPAP Submission Levels


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PPAP Submission Requirements

Requirement Level 1 Level 2 Level 3 Level 4 Level 5

1.Design Record R S S * R

2.Engineering Change Documents, if any R S S * R

3.Customer Engineering approval, if required R R S * R

4.Design FMEA R R S * R

5.Process Flow Diagrams R R S * R

6.Process FMEA R R S * R

7.Control Plan R R S * R

8.Measurement System Analysis studies R R S * R9.Dimensional Results R S S * R

10.Material, Performance Test Results R S S * R

11.Initial Process Studies R R S * R

12.Qualified Laboratory Documentation R S S * R

13.Appearance Approval Report (AAR), if applicable S S S * R

14.Sample Product R S S * R

15.Master Sample R R R * R

16.Checking Aids R R R * R

17.Records of Compliance With Customer Specific Requirements R R S * R

18.Part Submission Warrant S S S S R

19.Bulk Material Checklist S S S S R

S = The organization shall submit to the customer and retain a copy of records or documentation items at appropriate

locations

R = The organization shall retain at appropriate locations and make available to the customer upon request

* = The organization shall retain at the appropriate location and submit to the customer upon request


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Supplier PPAP Checklist

Checklists are generated electronicallywithin our CPSD Q-Pulse Database

Supplier Quality in conjunction with

plant representatives determine which

elements of a specific level will apply

Suppliers use this as a guide to

ensure all requested elements havebeen submitted

This template represents the default

expectations of each level, however

SQ can elect to add or decrease

requirements within any level

Level 3 is the default level for

submission unless otherwise

communicated


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PPAP SubmissionChecklist Example

Submit (S) = Supplier shallsubmit to Eaton & retain a

copy of records ordocumentation items atappropriate locations

Retain (R) = Supplier shallretain at appropriate

locations and make readilyavailable to Eaton upon

request

Waive (W) = Eaton waivessupplier responsibility ofperforming an activity.

Not AIAG


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Importance of Due Diligence through PPAP

Eaton Requirements Element Links Critical Systems

1. Part Submission Warrant (PSW)

2. Design Records 2. Design Records Requirements (Special Characteristics)

3. Engineering Change Documents

4. Customer Engineering Approval

5. DFMEA 5. DFMEA More Robust Design

6. Process Flow Diagram

7. PFMEA 7. PFMEA Robust Process

8. Control Plan9. Measurement System Analysis (MSA)

10. Dimensional Results 8. Control Plan Develop Process Control

11. Material, Performance Results

12. Initial Process Study

13. Qualified Laboratory Documentation 9. MSA Confirm Measurement

14.Appearance Approval Report (AAR)

15. Sample Product 12. Initial Process Study Verify and Improve capability

16. Master Sample

17. Checking Aids

18. CPSD specific requirements 18. CPSD Specific Customer Requirements

Tooling Information Form

Packaging Form

Specification Deviation Submit

Supplier PPAP Checklist

Diligence is critical because elements relate and build on each other


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Example: Definition of Risk

High Risk

Parts associated with multiple critical features, complex design, or

high end technology that is not yet established in the general

manufacturing environment

Suppliers quality system and/or quality performance is not to Eaton

satisfaction

Critical process being conducted eg heat treatment

Medium Risk

Parts that have at least one critical feature

Low Risk

Parts that have no critical features and can be manufactured by any

manufacturer in the commodity category

Catalogue Parts

Suppliers quality system is acceptable and

Suppliers quality performance can be demonstrated over time


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Electronic Submission Requirements

Eaton requests that all PPAPs be submittedelectronically or scanned / uploaded into

WISPER

Use of paper submission must have prior

approval by the SQ.

Submission must be received on or prior tothe

PPAP due date

Review and Approval Process: Eaton will attempt to review and provide feedback within 10 business

days


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PPAP Status

Approved

The part meets all Eaton requirements

Supplier is authorized to ship production quantities of the

part

Interim Approval

Permits shipment of part on a limited time or piece quantity

basis

Rejected

The part does not meet Eaton requirements, based on the

production lot from which it was taken and/or

accompanying documentation

Production quantities may not be

shipped before Eaton Approval


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Supplier Information
http://www.cooperindustries.com/content/public/en/power_systems/resources/library/supplier_information.htmlhttp://www.cooperindustries.com/content/public/en/power_systems/resources/library/supplier_information.html


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Element 1: Part Submission Warrant


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Part Submission Warrant (PSW)

Now, lets take a closer look

What is It?

Document required for all newly tooled orrevised products in which the supplier

confirms that inspections and tests on

production parts show conformance to

Eaton requirements

Objective or Purpose

Used to :

document part approval

provide key information

declare that the parts meet specification

When to Use It

Prior to shipping production parts

Part Submission WarrantPart Name Cust. Part Number

Show n on Draw ing Number Org. Part Number

Engineering Change Level Dated

Additional Engineering Changes Dated

Saf ety and/or Government Regulation Purchase Order No.

Checking Aid Number Checking Aid Eng. Change Level Dated

ORGANIZATION MANUFACTURING INFORMATION CUSTOMER SUBMITTAL INFORMATION

ORGANIZATION CODE CUSTOMER DIVISIONSupplier Name & Supplier /V endor Code Cus tomer Name/Div is ion

ADDRESSStreet Address Buyer/Buyer Code

CITY STATE ZIP APPLICATION

City Region Postal Code Country Application

MATERIALS REPORTING

Has customer-required Substances of Concern information been reported?

Submitted by IMDS or other customer format:

Are polymeric parts identified with appropriate ISO marking codes?

REASON FOR SUBMISSION (Check at least one)

Initial submission Change to Optional Construction or Material

Engineering Change(s) Sub-Supplier or Material Source Change

Tooling: Transfer, Replacement, Refurbishment, or additional Change in Part Processing

Correction of Discrepancy Parts produced at Additional Location

Tooling Inactive > than 1 year Other - please specify

REQUESTED SUBMISSION LEVEL (Che ck one )

Level 1 - Warrant only ( and for designated appearance items, an Appearance Approval Report) submitted to customer.

Level 2 - Warrant w ith product samples and limited supporting data submitted to customer.

Level 3 - Warrant w ith product samples and complete supporting data submitted to customer.

Level 4 - Warrant and other requirements as defined by customer.

Level 5 - Warrant w ith product samples and complete supporting data reviewed at organization's manufacturing location.

SUBMISSION RESULTS

The results for

Thes e resu lt s meet al l des ign rec ord requ irement s: ( If " NO" - Ex pl anat ion Requ ired )

Mold / Cavity / Production Process

DECLARATION

EXPLANATION/COMMENTS:

Is each Customer Tool properly tagged and numbered?

Organization Authorized Signature Date

Print Name

Title E-mail

FOR CUSTOMER USEONLY (IF APPLICABLE)

PPAP Warrant Disposition:

Customer Signature Date

Print Name Customer Tracking Number (optional)

NAME NUMBER

ECL DATEECL

Weight (kg)

Fax No.555-555-5555

Iaff irmthatthesamples representedby this warrantare representativeof ourparts, whichwere madeby a processthatmeets

allProduction Part ApprovalProcess Manual 4th EditionRequirements. Ifurther affirmthat thesesamples were produced atthe

productionrateof ____/____hours. Ialsocertify that documented evidence ofsuch compliance ison file andavailablefor your

review. Ihave noted any deviation fromthis declaration below.

Phone No.

Yes NO

dimensional measurements material and functional tests appearance criteria statistical process package

Yes No

Yes No

Yes No

Approved Rejected Other

n/a

Yes No n/a


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The approved Part Submission Warrant officially warrants

the parts and process are ready for production


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Production Run

PPAP data must be submitted from a

productionrunusing: Production equipment and tooling

Production employees

Production rate

Production process

All data reflects the actual productionprocess to be used at start-up!


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Run @ Rate

The purpose of a Run @ Rateis to verify the suppliers

manufacturing process is capable of producingcomponents that meet Eatons quality requirements, atquoted tooling capacity, for a specified period of time

Verification of the Run @ Rate will be at the Supplier

Quality Engineers (SQE) discretion. The supplier will benotified of the need to perform a Run @ Rate as early inthe process as possible.

The number of components to be produced during theRun @ Rate should be sufficient to demonstrate process

capability and will be predetermined by the SQE and thesupplier. Factors such as product complexity, shelf life, storage, cost and

single shift vs. multiple shift operations will be taken intoconsideration


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Reviewers Checklist Must be completely filled out

Must be signed by the supplier

P/N must match the PO

Product family submissions allowed

Submitted at the correct revision level

Submitted at the correct submission level

Specify the reason for submission



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Element 2: Design Records & Bubbled Part Prints


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Design Record & Bubble Prints

Objective or Purpose:

To document & provide a copy of the formal part print

To provide any additional engineering records for reference


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E2 Requirements

All submission should have 1 copy of the formal print Bubble print that supports the dimensional report

Must have all notes and specification circled and numbered

Must be clear and legible

Must include any reference dimensions

Start numbering in upper Left and continue clockwise

Any additional supporting information including

Reference prints

Sub-Assembly prints

Component prints with a different part number

Applicable material specifications

Applicable reference specifications Customer specified workmanship standards


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Bubble Print for Dimensional Report

Print bubble number must correspond to the Item number on the Dimensional Report


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Special CharacteristicsWhat is It?

A method of communicating specific requirements thatrequire additional control or care by personnel at the point of

manufacture or assembly

Includes both product and process characteristics

communicated on product requirements such

Part drawing

dFMEA

pFMEA

Process Control Plan

Design Special Characteristics:

Component features that are critical to the safety or functionality of the final product. Denoted on the component part

drawing and/or material specifications. Selected by the customer during the design phase.

Process Special Characteristics:

Special Characteristics are those features that most affect the outcome of a product or process. Controls must bedesigned and implemented as part of your companys advanced quality planning. Special attention is required during this

phase to identify and control variables that affect the conformance of the product.

Eatons expectation is that you will address all Special Characteristics (both Design and Process Characteristics) in

theControl Plan and ensure that you have a robust process for consistently achieving all CTQ (Critical to Quality)

requirements as that are defined in the CPSD part print.


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Eaton Special Characteristic Types

Required Control Dimension (RCD):A required control dimensions (RCD) is one of two types of Design Special Characteristics that requires

special care in the form of additional control or capability. The control is required to be in place during both

startup and on an ongoing basis. This can be done through statistical techniques, but can also be

accomplished through techniques such as 100% inspection, poke-yoke (error-proofing) etc.. Power

Systems designates an RCD using the Octagon symbol placed on the left-hand side of the stated

requirement.

Statistically Toleranced Dimensions (STD):

A statistically toleranced dimension (STD) is one of two types of Design Special Characteristics that requires

special care in the form of additional control and capability. All the same requirements of an RCD apply

except that in addition a STD has been found to have statistical significance and therefore capability is

required. This means that regardless of any other control method this dimension must demonstrate an initial

and ongoing process capability. Power Systems designates an STD design characteristic using the ASME

Y14.5M ST Symbol (elongated hexagon) placed on the right-hand side of the stated requirement. Capability

index requirements should follow the guidelines provided in this PPAP manual.


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Reviewers Checklist Must be clean and legible Bubble print

Must be correct CPSD Part # and Revision

Every requirement must have a separate bubble

Dimensions Notes

Special Characteristics

Referenced specifications

Verify that no other prints need to be submitted

Sub-assemblies

Component level detail

Design Records & Bubbled Prints


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Morning Break

10 Minutes


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Element 3: Authorized Engineering Change Documents

Authorized Engineering Change


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Authorized Engineering ChangeDocuments


To provide any pertinent change information for reference

This is a placeholder for all relevant information not covered in

the part print :

ECNs Specifications

Feasibility studies

Supplier Change Requests

Emails

Sub-assembly drawings

Life or reliability testing requirements

This element is typically used when changes occur to the design documentation


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Reviewers Checklist CPSD ECNs must be approved, not pending

Print change submissions must have current prints

Marked up prints are not acceptable for PPAP

Supplier initiated changes must have approved Supplier ChangeRequest (SCR) form in this section.

Emails can only clarify requirements, not define them

Emails cannot re-define a requirement in lieu of an upcoming print

change

Example: I am submitting REV A even though a REV B print is coming

because this email requested me to make the change.

Answer :Then submit PPA to REV B not REV A

Approved Engineering Change Documentation


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Element 4: Customer Engineering Approvals


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Customer Engineering Approvals

Customer Engineering Approvals are used to demonstrate pre-

approval by Eatons customer of a design.

Customer Engineering Approvals are not required for supplier

submissions.

In the event that this would be required in the future we have

maintained a placeholder within the Power Systems

requirements.


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Element 5: Design FMEA (DFMEA)


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Design FMEA


To show evidence that potential failure modes and risks have been addressed atthe design level.

Materials selection

Tolerance stack-up

Software

Interfaces

DVP&R (life cycle tests)

When is it Required?

Required only when the part is designed by the supplier.

Guidance:

DFMEA must follow AIAG compliant format/guidelines

Must incorporate all design special characteristics

Can be applied to a family of parts

Can be proprietary and if there is a concern notify Quality

DFMEA highlights and reduces design risks


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DFMEA Common Pitfalls One time document

Must be continuously reviewed and updated What if the latest change or revision has a significant impact?

Not submitted or reviewed with supplier

The After Thought

Completed after drawing and production release

Does not consider all potential failure modes

Assumes singular or linear failure points

Star/ Planet Alignment Phenomenon

Tolerance is theoretical and not reviewed with consideration of available manufacturingtechnologies

Detection are over stated

Single sample test

Critical and/or Special Characteristics not identified

Only considers full assembly Not completed to correct level component, sub assembly, assembly, product

Family based DFMEA not all inclusive

Not reviewed for specific/ custom application/ designs


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Reviewers Checklist DFMEA is only required if designed by the supplier.

Must address all special characteristics

Must show evidence of objective design evaluation

Document is reviewed by a team no a single engineer

Sate should show release prior to print release

Severity, Occurrence and Detection must be compliant with AiAG

guidelines

Must take the technical/physical limits of the manufacturing/assembly

process into consideration.

Design FMEA


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Key Relationships

Process

Instructions

Process

FMEA

Characteristic

Matrix

Process

Flowchart

Control

Plan


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Element 6: Process Flow Diagrams


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Process Steps

New/Revised Process

Steps

Project Idea

Fill OutMasterForm

with InitialInformation

IsHardSavings> $???

DoestheProjectInvolve

OnlyYourGroup?


>3Depts.outsideEng?

DoestheProjectInvolve>2Groupsin

Eng?

Do youhaveBB/GBtoAssist/Workthe

project?

Preferto workthisprojectwithin your

area?

6SigmaProject

DepartmentorGroupProject

Yes

No

Yes

No

Yes

No

No

No

Yes

Yes

Yes No

EnterRemainingInformation onMasterForm

MasterForm WillGenerateContract

FinanceApprovaland Signature

OtherRequiredSignatures:

SegmentCEOChampion

ProcessOwnerBBorGB

6SigmaAssignsProjectNumber

GetWO Assigned

Begin/WorkProject

Follow DMAICorDFSS process

MonitorProgressthrough PowerSteering and

MonthlyFinancialReviews

CompleteProject(Hasto befullyDocumented



Champion:DirT&EProcessOwnerProjectOwner

DeptBBorMBB




OtherRequiredSignatures:Champion:

ProcessOwnerProjectOwner

DeptGB/BB/MBB

Group AssignsProjectNumber

GetDLNAssigned

MonitorProgressthrough Bi-

WeeklyUpdatesand Monthly

Reviews

Begin/WorkProject


CompleteProject(Hasto befullyDocumented)




DeptBBorMBB

CompleteallDocumentation

including a(1)PageClose-

outSheet

CloseProject



outSheet

Final ProjectReview

CloseProject

Final ProjectReview

6Sigma ProjectHighLevel ProcessMap

Department/GroupProject

HighLevel ProcessMap

Process Flowchart

Process StepKey

Process

Input

Potential

Failure Mode

Potential

Failure Effects

SE

V

Potential CausesOC

C

Current ControlsDE

T

RP

N

EO

C

Actions

Recommended

Receive

Payment

C hecks D el ay i n te rnal

mail

AR balance does

not go down7

Inadequate

staffing in mail

room 7

None

1 0 4 90

Investigate mail room

staffing and associated

processes

Identify

Customer

Wire

Transfer

reference

line

Information not

supplied

AR balance is

past due

10

Customeror bank

did not include

name and/or

account info on

wire transfer

5

Acct identifies problem

when trying to apply

payment5 250

Poka-Yoke wire transer

process

Ident i fy Invoice Checks Incorrect

invoice

supplied

Invoice shows

outstanding (AR

balance does go

down)

5

Customer error

5

Customer mightc atch

it when reviewing the

next statement 1 0 2 50

Provide payment stub

with statementfor each

invoice

Ident i fy Invoice Checks Invoice number

notsupplied

Invoice shows

outstanding (ARbalance does go

down)

5

Customer error

10


when trying to applypayment 5 250


with statementfor eachinvoice

Process FMEA

Control Plan

Tool Interaction

Holy Trilogy of Control Documentation


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Process Flow Diagrams (Maps)


To document the entire manufacturing process for a part To clarify the steps in manufacturing the part

To look for waste (lean manufacturing)

Guidance:

Process flow must include:

The entire manufacturing process (receiving through shipping)

All key steps in the process

All offline activities (such as measurement, inspection and handling)

Identification of areas containing nonconforming material

Scrap, defective and rework parts

Process steps must match both the Control plan and the PFMEA

DFMEA highlights and reduces design risks


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Process Flow Diagram

What is It? A visual diagram of the entire process

from receiving through shipping,including outside processes andservices

Objective or Purpose To help people see the real

process. Process maps can be usedto understand the followingcharacteristics of a process:

Set-by-step process linkage

Offline activities (measurement,inspection, handling)

Rework, scrap

When to Use It To understand how a process is done

Prior to completing the PFMEA


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Process Flow Diagrams

PROCESS / INSPECTION FLOWCHART

Product Program Issue Date ECL ECL

Supplier Name ORGANIZATION Part Name NAME

Supplier Location CITY STATE Part Number NUMBER

Legend:

Operation Transportation Inspection Delay Storage

Operation or Event Description of Evaluation

Operation or Event and Analysis MethodsSTEP

The process flow diagram

utilizes these symbols toclearly identify each stepin the process


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Process Flow Diagram - Examples


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Process Flow Diagram - Examples


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Break Out Session. 30 minutes

Completing a Process Map.


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Process Mapping

Lego Process Mapping.

In your team I want you to developa process map for each stage in theprocess to construct a Lego set.

Reviewing all the steps, inputs andoutputs of this process.


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Preparing the Process Map

Team Effort: Manufacturing engineers

Line operators

Line supervisors

Maintenance technicians

Possible Inputs to Mapping: Brainstorming Operator manuals

Engineering specifications Operator experience

6Ms Man, Machine (Equipment), Method (Procedures),

Measurement, Materials, Mother Nature (Environment)


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Team Report Outs 15 minutes (3 teams)

P M S


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Process Map Summary

Process Mapping Provides Inputs to

Potential Failure Mode Effect Analysis

Control Plan

Capability Studies

MSA

Process Mapping helps us gain

process knowledge!


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Reviewers Checklist Process Flow must identify each step in the process

Match both PFMEA and Control Plan

Should include abnormal handling processes

Scrap

Rework

Extended Life Testing

Process Flow must include all phases of the process

Receiving of raw material

Part manufacturing

Offline inspections and checks

Assembly

Testing

Shipping

Transportation

Process Flow Diagrams


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Element 7: Process FMEA (PFMEA)


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Process Steps

New/Revised Process

Steps

Project Idea

Fill OutMasterForm


IsHardSavings> $???


OnlyYourGroup?


>3Depts.outsideEng?


Eng?


project?


area?

6SigmaProject


Yes

No

Yes

No

Yes

No

No

No

Yes

Yes

Yes No





SegmentCEOChampion

ProcessOwnerBBorGB


GetWO Assigned

Begin/WorkProject








DeptBBorMBB






DeptGB/BB/MBB


GetDLNAssigned



Reviews

Begin/WorkProject






DeptBBorMBB



outSheet

CloseProject



outSheet

Final ProjectReview

CloseProject

Final ProjectReview

6Sigma Project

HighLevel ProcessMap

Department/GroupProjectHighLevel ProcessMap

Process Flowchart

Process StepKey

Process

Input

Potential

Failure Mode

Potential

Failure Effects

SE

V

Potential CausesOC

C

Current ControlsDE

T

RP

N

EO

C

Actions

Recommended

Receive

Payment


mail

AR balance does

not go down7

Inadequate

staffing in mail

room 7

None

1 0 4 90



processes

Identify

Customer

Wire

Transfer

reference

line

Information not

supplied

AR balance is

past due

10

Customeror bank

did not include

name and/or

account info on

wire transfer

5



payment5 250


process


invoice

supplied

Invoice shows

outstanding (AR

balance does go

down)

5

Customer error

5






invoice


notsupplied

Invoice shows


down)

5

Customer error

10





Process FMEA

Control Plan

Tool Interaction



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FMEA Origin

Created by NASA following Apollo 1 mission

failure

Allows us to take a proactive approach to what

can go wrong in a process and manage our

risks better


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Process FMEA (PFMEA)

What is It?

A tool used to identify and prioritize riskareas and their mitigation plans.

Objective or Purpose Identifies potential failure modes, causes,

and effects. Inputs come from the processflow diagram.

Identifies key inputs which positively ornegatively affect quality, reliability andsafety of a product or process.

Denotes Special Characteristics ofProduct/Process that impact the ultimatesafety/performance of the end product.

When to Use It

After completion of the process flowdiagram.

Prior to tooling for production

The PFMEA should be completed

using a cross-funct ionalteam!

IMPORTANT!


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PFMEA Step 1

Using thecompleted

Process

Flow

Diagram,

enter the

process

step.

Failure Modes

For each Process Input,

determine the ways in

which the input can go

wrong.

Concisely list the

performance

requirement(s).

TIPS

There should be at least one failure mode for each input.


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Potential Failure Mode Discuss with the team all credible Potential Failure Modes.

Team should be able to pose and answer the following questions:

How can the process/part fail to meet requirements?

Regardless of Eng specs, what would a customer consider objectionable?

In each instance, the assumption is made that the failure could occur, but will not necessarily

occur:

Each failure mode should be credible

Do not list acts of God or freak accidents A description of non-conformance

Assume incoming parts are correct

Remember to consider subsequent operations

Examples of failure modes include:

Potential failure modes should be described in physical or technical terms, not as a symptomnoticeable by the customer.

Burred Bent Hole off location

Cracked Hole to shallow Hole missing

Handling Damage Dirty Hole to deep

Surface too rough Corrosion Open circuit


71/240


PFMEA Step 2

Potential Failure Effects

For each Failure Mode,

determine what effect

the specific failurecould have on the

process output.

TIPS

There should be at least one failure effect for each failure mode.

Effects should be specific, clear, and leave no doubt to the uninformed reviewer.


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Potential Effect(s) of Failure

Potential effects of failure are defined as the effects of the failure on the customer(s)

o Describe in terms of what the customer might notice or experienceo State clearly if the failure mode could impact safety or cause noncompliance to regulations

For the end user the effects should always be stated in term of product or system

performance such as:

Noise Rough Erratic

Operation

Excessive Effort Inoperative Unpleasant

Odor

Unstable

Operation

Impaired

Draft Intermittent

Operation

Poor

Appearance

Leaks Control

Impaired

Rework

Repairs

Scrap

If the customer is the next operation the effects should be stated in terms of

process/operation performance, such as:

Cannot fasten Does not fit Cannot bore/tap Does not connect Cannot mount

Does not match Cannot face Causes Excessive

tool wear

Damages

Equipment

Endangers Operator


73/240


PFMEA Step 3

Potential Causes

For each Failure Mode,

determine the possible

cause of the failure.

TIPS

There should be at least one potential cause for each failure mode.


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Potential Cause(s) of Failure

Potential causes are defined as how the failure could occur, and described in terms

of something that can be corrected or controlled.

Only specific errors should be listed, ambiguous phrases such as operator error,

machine malfunction, etc., should be avoided. Acceptable alternatives would be

operator failed to install seal, or over temperature set incorrectly.

The causes should be described so that remedial efforts can be aimed at those

causes which are pertinent. Typical failure causes may include but are not limited

to:

Improper torque

over/under

Improper weld

current, time,

pressure

Inaccurate Gauging Improper Heat

Treat time,

temperature

Inadequate

gating/venting

Inadequate or no

lubrication

Part missing or

mislocated

Worn locator Worn Tool Chip on locator

Broken tool Improper Machine

Setup

Improper

programming

Incorrect Software

version

Non validated test

system


75/240


PFMEA Step 4

Current Controls

For each potential

cause, list the current

method used for

preventing or detecting

failure.

TIPS

This step in the FMEA begins to identify initial shortcomings or gaps in the current control plan. If a procedure exists, enter the document number. If no current control exists, list as none.


76/240


PFMEA Step 5

Assign Severity

(How serious is the

effect if it fails?)

Assign Occurrence

(How likely is the

cause to occur?)

Assign Detection

(How easily can the

cause or failure

mode be detected?)

Severity, Occurrence and Detection rating details on next slide

PFMEA - Definition of Terms


77/240


Severity (of Effect) - severity of the effect on the Customerand other stakeholders (Higher Value = Higher Severity)

Occurrence (of Cause) - frequency with which a givenCause occurs and creates Failure Mode. (Higher Value = HigherProbability of Occurrence)

Detection (Capability of Current Controls) -ability of current control scheme to detect the cause before creating thefailure mode and/or the failure mode before suffering the effect (HigherValue = Lower Ability to Detect)

Caution: Notice the scale difference for Detection!


78/240


An Example of Rating Definitions


79/240


PFMEA Step 5

Calculate the Risk Priority Number

RPN = Severity x Occurrence x Detection

TIPS

The RPN is used to prioritize the most critical risks identified in the first half of the FMEA.

High RPNs are flags to take effort to reduce the calculated risk.

Regardless of RPN, high Severityscores (9 or 10) should be given special attention.

A l i h PFMEA


80/240


Once the RPN Numbers are

determined, they can be used to

prioritize the most significant failure

modes.

Sort the FMEA by the RPN numbers.

Graphical and statistical tools can help

the team to continually improve.

RPNs DO NOT set a threshold for RPN.

Focus on Continuous Improvement.

DO NOT forget to address high

Severityscores first.

Pareto Chart

?How many items should be

the focus of the next steps?

Sort by RPN to determine

the most significant

failure modes

Analyzing the PFMEA

PFMEA R di ti G id li


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PFMEA Remediation Guidelines

Severity can only be improved by a design change to the productor process

Occurrence can only be reduced by a change which removesor controls a cause. Examples are redundancy, substituting a morereliable component or function or mistake-proofing.

Detectioncanbe reduced by improving detection. Examplesare mistake-proofing, simplification and statistically sound monitoring.

In general, reducing the Occurrenceis preferable to improving the Detection

PFMEA St 7


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PFMEA Step 7

For the high RPN numbers,

determine the

recommended actions.

Determine Actions Recommendedto reduce High RPNs

PFMEA St 8 d 9


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PFMEA Step 8 and 9

Resp (responsibility)

Assign a specific person

who will be responsible

for recommended actions.

Actions Taken

As actions are identified

and completed, document

in the Actions Taken

column.

SEV, OCC, DET, RPN

As actions are complete

reassess Severity,

Occurrence, and Detection

and recalculate RPN.

S St T C l t FMEA


84/240


Summary Steps To Complete a FMEA

1. For each Process Input, determine the ways in which the Process Step

can go wrong (these are Failure Modes).2. For each Failure Mode associated with the inputs, determine Effectson

the outputs.

3. Identify potential Causesof each Failure Mode.

4. List the Current Controls for each Cause.

5. Assign Severity, Occurrence and Detection ratings after creating aratings key appropriate for your project.

6. Calculate RPN.

7. Determine Recommended Actions to reduce High RPNs.

8. Take appropriate Actions and Document.

9. Recalculate RPNs.10. Revisitsteps 7 and 8 until all the significant RPNs have been

addressed.

L h


85/240


Lunch

45 minutes


86/240



Completing a PFMEA.

PFMEA


87/240


PFMEA

Lego PFMEA.

In your team, using the PFC youjust created, develop a PFMEA foryour planned Lego assemblyprocess

Choose a PFMEA template fromthe AIAG Core Tools file

Use the provided evaluation

criteria to rank severity, occurrenceand detection

Example


88/240


Example

Process or

Product

Name:

Low Voltage Busway

Epoxy Insulation -

GF&P

Prepared by: D. Yount Page ____ of ____

Responsible: Mario SeppulvedaGF&P, Ladd Kelly C-H

FMEA Date (Orig) _July 99__ (Rev) 2, Nov 99___(Rev 3), Nov 99_

Process

Step/Input

Potential Failure

Mode

Potential Failure

Effects

S

E

V

Potential Causes

O

C

C

Current Controls

D

E

T

R

P

N

Actions

RecommendedRe sp. Actions Ta ke n

S

E

V

O

C

C

What is the

process step/

Input under

investigation?

In what ways does the

Key Input go wrong?

What is the impact on

the Key Output

Variables (Customer

Requirements) or internal

requirements?

Ho

w

Severeisthe

effecttotheWhat causes the Key

Input to go wrong?

Howo

ftendoescause

orFMo

ccur?What are the existing

controls and procedures

(inspection and test) that

prevent either the cause or

the Failure Mode? Should

include an SOP number. How

wellcanyou

detec

tcauseorFM? What are the

actions for

reducing the

occurrence of the

Cause, or

improvingdetection?

Should have

Whose

Responsibl

e for the

recommend

ed action?

What are the

completed actions

taken with the

recalculated RPN?

Be sure to include

completionmonth/year

Grind (12) Sanding disk grit

incorrect

Irregular contact surface,

plating surface rough5

Vendor supplied incorrect

disk1

Supervisor inspects

incoming material, then

releases for use4 20

Need to create

work instruction to

document

inspection

M.

Sepulveda

Target complete

11/99

epoxy build up on parts

due to drag out not being

blown off

8

operator error

7

OJT for operator

9 504

Re train operators

both shifts, review

deisgn & operation

Ladd Kelley Target complete

11/99 8 3

Masking (2) rough surface where

the part will be coated

w/epoxy

failed visual or high pot

test 9

poor sanding, weld slag,

weld splatter, metal chips

on bars10

operator training OJT, visual

inspection , (SOP ?) 5 450

Define causes,

train Fab, Epoxy

and Plating

L. Kelley,

M.

Sepulveda

Target complete

11/99

Equipment failure, pins

break, welds break on

rack

bar falls off carrier,

possible to damage tank

or other equipment, or10

part fatigue, part failure

4

loader visual inspection

7 280

New racks, re train

operators to

inspect, review PM

M.

Sepulveda,

L. Kelley

Target complete 1/00

10 4

De Masking

(8)

Tape not removed

correctly

Epoxy on contact

surfaces, damaged

epoxy from contact 9

bars hung to close

together, too many bars

on a rack, not enough

resources demasking,

5

operator training OJT, work

instruction for masking SOP6 270

review modified

rack design,

elimintae demask

where possible,

M.

Sepulveda,

L. Kelley

Target complete

11/99

What

is theInput

What

can go

wrongwith the

Input?

What canbe done?

What is

the Effect

on the

Outputs?

What are

theCauses?

How are

these foundor

prevented?

How

Bad?

How

Often?How

well

?

PFMEA - Example


89/240


Process

Step/InputPotential Failure Mode Potential Failure Effects

SE

V

Potential CausesOC

C

Current ControlsDE

T

RP

N

Unload and Pack Scratched Part rejected at next dept.8

Improper Handling10

No written (attended training)6 480

1 2 3 4 5

6 7

8 9

10 11 12

13 14

Hint: Follow the flow shown above, where the team

exhausts causes and controls for one failure mode and each

related effect before moving on to another

Report Outs


90/240


Report Outs

2 Teams 10 minutes



91/240


Reviewers Checklist

Verify there is a system for prioritizing risk of failure such as high RPNnumbers

Make sure that high RPN process concerns are carried over into the control

plan

Make sure that all critical failure modes are addressed

Safety Form, fit, function

Material concerns

See AIAG Core Tools for detailed checklist

All special characteristics have been addressed as individual line items

Shows evidence of cross functional participation

Severity, Occurrence and detection must be compliant with AIAG guidelines andscored within reason

Make sure that action is being taken on higher RPN line items & the action will

actually have impact.


PFMEA: Tips and Lessons Learned


92/240


PFMEA: Tips and Lessons Learned

Collaborative Effort: Do not try alone, use a group Very laborious: Time consuming process for initial

construction. Take necessary breaks

Action items are required for completion

Train team ahead of time by explaining scoring criteria Proper preparation is needed for meetings

Summarize often: FMEA is a livingdocument,continual updates makes this a routine part of the

process, can be done on quarterly or semi-annualbasis or as required by a generated defect.

Process FMEA (PFMEA) Typical Mistakes


93/240


Process FMEA (PFMEA) Typical Mistakes

Examples of typical PFMEA Mistakes Misapplication of Severity, Occurrence and Detection

Redefining Severity, Occurrence and Detection

Over estimating the effectiveness of the Recommended Action

Applying thresholds Not recognizing all potential failures

Failure to properly identify the customer

Misapplication of ranking scales

Confusing the Failure modes with Effects or Causes Allowing the PFMEA to turn into a design review


94/240


Element 8: Control Plan



95/240


Process Steps

New/Revised Process

Steps

Project Idea

Fill OutMasterForm


IsHardSavings> $???


OnlyYourGroup?


>3Depts.outsideEng?


Eng?


project?


area?

6SigmaProject


Yes

No

Yes

No

Yes

No

No

No

Yes

Yes

Yes No





SegmentCEOChampion

ProcessOwnerBBorGB


GetWO Assigned

Begin/WorkProject








DeptBBorMBB






DeptGB/BB/MBB


GetDLNAssigned



Reviews

Begin/WorkProject






DeptBBorMBB



outSheet

CloseProject



outSheet

Final ProjectReview

CloseProject

Final ProjectReview

6Sigma ProjectHighLevel ProcessMap

Department/GroupProjectHighLevel ProcessMap

Process Flowchart

Process Step

Key

ProcessInput

Potential

Failure Mode

Potential

Failure Effects

S

EV

Potential Causes

O

CC

Current Controls

D

ET

R

PN

E

OC

Actions

Recommended

Receive

Payment


mail

AR balance does

not go down7

Inadequate

staffing in mail

room 7

None

1 0 4 90



processes

Identify

Customer

Wire

Transfer

reference

line

Information not

supplied

AR balance is

past due

10

Customeror bank

did not include

name and/or

account info on

wire transfer

5



payment5 250


process


invoice

supplied

Invoice shows

outstanding (AR

balance does go

down)

5

Customer error

5






invoice


notsupplied

Invoice shows


down)

5

Customer error

10





Process FMEA

Control Plan

Tool Interaction


Control Plan


96/240


Control Plan

What is It? A document that defines the operations,

processes, materials, equipment, methodologies,

and special characteristics integral to the

manufacturing process.

Purpose:

To communicate the suppliers decisions duringthe entire manufacturing process from materials

purchase through final packaging.

When to Use It Implementation of new process

Implementing a process change

Since processes are expected to be continuously

updated and improved, the control plan

is a living document!

Control Plan Goals


97/240


Control Plan - Goals

Specifically the control plan should address the following:

Methods of production

Identification of Special Characteristics controls

Secondary or outsourced operations

Materials and their physical and chemical characteristics

Types of process equipment at each operation

Types of test equipment at each operation

Types of test equipment used to measure each characteristic

Specifications, sampling strategy, control and reaction methods used

Periodic conformance testing and product verification

Control Plans address all key process steps

The Control Plan Form


98/240



CONTROL PLAN

Control Plan Number Key Contact/Phone Date (Orig.) Date (Rev.)

FILE.XLS 555-555-5555Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.)

NUMBER ECLPart Name/Description Organization/Plant Approval/Date Customer Quality Approval/Date (If Req'd.)

NAMEOrganization/Plant Organization Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)

ORGANIZATION

PRODUCT/PROCESS EVALUATION/ SAMPLESPECIFICATION/ MEASUREMENT

TOLERANCE TECHNIQUE

CODE

REACTIONPLAN

1/1/1996 1/1/1996

MACHINE,

DEVICEJIG, TOOLS

FOR MFG.NO. PRODUCT PROCESS

SPECIAL

CHAR.

CLASS SIZE

PART/

PROCESS

NUMBER

PROCESS NAME/

OPERATION

DESCRIPTION FREQ.

CONTROL

METHOD

CHARACTERISTICS METHODS

Prototype Pre-Launch Production



99/240


CONTROL PLAN





ORGANIZATION


TOLERANCE TECHNIQUE

CODE

REACTIONPLAN

1/1/1996 1/1/1996

MACHINE,

DEVICEJIG, TOOLS


SPECIAL

CHAR.CLASS SIZE

PART/

PROCESSNUMBER

PROCESS NAME/

OPERATIONDESCRIPTION FREQ.

CONTROL

METHOD




Administrative SectionIdentifies part number and description,

supplier, required approval signatures,

and dates.



100/240


CONTROL PLAN





ORGANIZATION

PRODUCT/PROCESS EVALUATION/ SAMPLE

SPECIFICATION/ MEASUREMENT

TOLERANCE TECHNIQUE

CODE

REACTION

PLAN

1/1/1996 1/1/1996

MACHINE,

DEVICE

JIG, TOOLS


SPECIAL

CHAR.

CLASS SIZE

PART/

PROCESS

NUMBER

PROCESS NAME/

OPERATION

DESCRIPTION FREQ.

CONTROL

METHOD




3 Distinct Phases

1. Prototype a description of the dimensional measurements and

material and performance tests that will occur during Prototype build.

2. Pre-Launch a description of the dimensional measurements and

material and performance tests that will occur after Prototype andbefore full Production.

3. Production a comprehensive documentation of product/process

characteristics, process controls, tests, and measurement systems that

will occur during mass production



101/240


CONTROL PLAN





ORGANIZATION


TOLERANCE TECHNIQUE

CODE

REACTION

PLAN

1/1/1996 1/1/1996

MACHINE,

DEVICE

JIG, TOOLS


SPECIAL

CHAR.CLASS SIZE

PART/

PROCESSNUMBER

PROCESS NAME/


CONTROL

METHOD




Each stage of produ ct ion and test ing. Can be:

Each operation indicated by the process flow

Each workstation Each machine

Include testing and audits

Process Number should cross reference with PFMEA

and Process Map



102/240


CONTROL PLAN





ORGANIZATION


TOLERANCE TECHNIQUE

CODE

REACTION

PLAN

1/1/1996 1/1/1996

MACHINE,

DEVICE

JIG, TOOLS


SPECIAL

CHAR.CLASS SIZE

PART/

PROCESSNUMBER

PROCESS NAME/


CONTROL

METHOD




Produ ct character ist icsthat are important. These can be

determined by referencing:

ST Dimensions on the drawing

Customer critical characteristics

Process critical characteristics

There may be several for each operation

Can be dimensional, performance or visual criteria



103/240



Process parametersthat are important. A process

parameter is a setting made within a process that effects

the variation within the operation. Examples include: Temperature (molding, heat treat, etc.)

Pressure

Fixture settings

Speed

Torque

Best if determined with DOE or other structured tool.



104/240


CONTROL PLAN





ORGANIZATION


TOLERANCE TECHNIQUE

CODE

REACTION

PLAN

1/1/1996 1/1/1996

MACHINE,

DEVICE

JIG, TOOLS


SPECIAL

CHAR.CLASS SIZE

PART/

PROCESSNUMBER

PROCESS NAME/


CONTROL

METHOD




Classrefers to whether the characteristic is denoted as a

Statistical Tolerance (ST) or Required Control (RC)

dimension on the drawing.

If so, then some sort of statistical evaluation & controlmust be used during production.

This is linked to PR4 special characteristics in EQS



105/240


CONTROL PLAN





ORGANIZATION


TOLERANCE TECHNIQUE

CODE

REACTION

PLAN

1/1/1996 1/1/1996

MACHINE,

DEVICE

JIG, TOOLS


SPECIAL

CHAR.CLASS SIZE

PART/

PROCESSNUMBER

PROCESS NAME/


CONTROL

METHOD




The criteria the product characteristic needs to meet.

This can either be taken from the drawing or be visual

criteria not listed in engineering documentation.

OR

This is the process parameter setting value that the

process must be run to ensure acceptable product.



106/240


CONTROL PLAN





ORGANIZATION


TOLERANCE TECHNIQUE

CODE

REACTION

PLAN

1/1/1996 1/1/1996

MACHINE,

DEVICE

JIG, TOOLS


SPECIAL

CHAR.CLASS SIZE

PART/

PROCESSNUMBER

PROCESS NAME/


CONTROL

METHOD




How is the characteristic or parameter going to

measured? Examples include:

Caliper

Visual

Fixture

Test equipment

Note that for critical characteristics and ST dimensions, a

gage R&R should be performed.



107/240


CONTROL PLAN





ORGANIZATION


TOLERANCE TECHNIQUE

CODE

REACTION

PLAN

1/1/1996 1/1/1996

MACHINE,

DEVICE

JIG, TOOLS


SPECIAL

CHAR.CLASS SIZE

PART/

PROCESSNUMBER

PROCESS NAME/


CONTROL

METHOD




How many parts will be measured and how often.

Examples:

Final testing, visual criteria 100%

SPC, Audit,

The sample size and frequency



108/240


CONTROL PLAN





ORGANIZATION


TOLERANCE TECHNIQUE

CODE

REACTION

PLAN

1/1/1996 1/1/1996

MACHINE,

DEVICE

JIG, TOOLS


SPECIAL

CHAR.CLASS SIZE

PART/

PROCESSNUMBER

PROCESS NAME/


CONTROL

METHOD




How the characteristic or parameter will be controlled

(this is the record) Examples include:

Xbar/R Chart

NP Chart Pre-control Chart

Checklist

Log sheet

Mistake proofing

1st piece inspection Lab report



109/240


CONTROL PLAN





ORGANIZATION


TOLERANCE TECHNIQUE

CODE

REACTION

PLAN

1/1/1996 1/1/1996

MACHINE,

DEVICE

JIG, TOOLS


SPECIAL

CHAR.CLASS SIZE

PART/

PROCESSNUMBER

PROCESS NAME/


CONTROL

METHOD




What happens when the characteristic or parameter is

found to be out of control. Must include:

Segregation of nonconforming product

Correction methodMay include (as appropriate):

Sorting

Rework/Repair

Customer notification

Control Plans: Audit Plans


110/240


Control Plans: Audit Plans

Audit plans can be included in the control plan as a separate line.

Auditing is an important tool for control.

Process auditing should be a key element of the quality system of a

business.

Audits generally cover:

Effectiveness of controls Control plan (say) vs. what is actually done (do)

Audits should be objective (done by internal or external third parties if

possible).

Audit frequencies should be based on balancing level of risk (FMEA)and cost.

Control Plan Example


111/240


Control Plan Example

Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.)002 T. Smith / 313-555-5555 11/29/2009 2/20/2010

Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.)

54321231 / D Erin Hope, Alan Burt, Ken Light

Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.)

Electronic Circuit Board

Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)

ACR Control 439412

Size Freq.

2

Soldering

Connections

Wave

solder

machine

Wave

solder

height 2.0 +/- .25 mc

Sensor

continuity

check 100% Continuous

Automated

inspection

(error

proofing)

Adjust and

retest

Flux

concen -

tration Standard #302B

Test sampling

lab

environment 1 pc 4 hours x-MR chart

Segregate

and retest


Reaction

Plan

SampleProduct/Process

Specification/

Tolerance

Evaluation /

Measurement

Technique

Control

Method

CONTROL PLAN

Part /

Process

Number

Process Name

/ Operation

Description

Machine,

Device,

Jig, Tools,

for MFG.

Characteristics

Special

Char.

Class

No. Product Process

Methods

A supplier manufactures a circuit board with electronic components soldered on the

board. Properly soldered connections are the major product characteristics. Two major

process characteristics for the wave solder machine are solder level and flux

concentration. An automated feeder controls the solder level by sensing the level of

solder and feeding in additional solder as the level is reduced. This characteristic is

measured 100% by checking electrically for continuity. The flux must be sampled and

tested for the concentration level.

Control Plan Common Pitfalls


112/240


Control Plan Common Pitfalls

One time document Must be continuously reviewed and updated

What if the latest change or revision has a significant impact?

Not consistent with Process Flow or PpFMEA

Reaction Plan not specific enough the tell an operator or supervisorwhat to do

Assumes singular or linear failure points

Star/ Planet Alignment Phenomenon

Process Characteristics not identified

Evaluation Measurement/ Detection tools not specifically identified

Critical and/or Special Characteristics not identified Family based Control Plan not all inclusive

Not reviewed for specific/ custom application/ designs


113/240



Completing a Control Plan.

Create a Control Plan


114/240


Lego Control Plan

In your teams, using the PFC andPFMEA you just created, develop aControl Plan for your process to

construct a Lego model.

For assembly process steps, inventyour own specifications

For receiving inspection of Legoblocks, you may use the dimensionson this picture and a .01mm tolerance

Break


115/240

117 117

10 Minutes


116/240


Report Outs 2 Teams 10 mins

Control Plan: Reviewers Checklist


117/240


Remember the Control Plan is a planning tool Use it to decide what you should be doing

The AIAG format will help make sure the plan makes sense and is complete

Use process flow diagram a